Comments and Concerns on the application made by Prof. Glenda Gray in respect of HIV vaccine clinical trial of genetically modified organism (MRKAd5 HIV-1 gag/pol/nef)

Comments and concerns

It should be noted that this submission is written in the context of a country that is devastated by HIV-AIDS at every level. That solutions are needed for this is without question. However, the use of a contested technology such as genetic engineering / genetic modification is disputed. The African Centre for Biosafety (ACB) has, in the past, made comment to the Department of Agriculture on applications relating to genetically modified food and agricultural crops.

This application for a clinical trial of a GM vaccine is the first medical application that ACB has commented on. The lack of information in the public domain became quickly evident. Brief details were obtained from the press release informing the public of the application, but further information was not available. To comment effectively on an application, and therefore for the public participation process to work, it is important to have as much relevant information as possible.

Although ACB is a South African public interest organisation, the applicant from a South African public interest research group, and the 3000 participants planned for the trial will be people living in South Africa, detailed information was not easily obtained. There is a significant difference between applications such as this medical application and applications for genetically modified (GM) food and other agricultural crops – the restrictions and safety issues and checks around this application are extensive and detailed. It is correct that they should be, but similar stringency should be applied in South Africa to GM food and agricultural crops.

From some points of view it can be stated that the risk assessment is carefully planned and interpreted. It does, however, leave a number of unanswered questions related to the health of the vaccinees as well as the creation of new recombinant viruses and non-target effects. There are concerns with the use of adenoviruses, aspects of the risk assessment, the definition of risk and with elements of the application.

Not having access to the Prior Informed Consent component of the application, has also meant that it is impossible to assess whether the vaccinees will be adequately informed about the full nature of the clinical trial that they are going to participate in.

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